Conference 8 – Complaint #4336
The following individuals were present to discuss the complaint:
1. Troy Albright – Pharmacist – Respondent
2. Ken Baker – Legal Counsel for Mr. Albright
President Foy opened the discussion by asking Mr. Waggoner to give a brief overview of the complaint.
Mr. Waggoner stated that the Board Office received a call from Banner Good Samaritan Regional Medical Center on 11/27/2013 concerning the discovery of a contaminated vial of
Calcium Glucontate 10% injection. It was determined that the contaminated vials were made by Rx Formualtions.
Mr. Waggoner stated that he visited Banner Good Samaritan and Rx Formulations. Mr. Waggoner stated that he noticed the black particles in the vial at Banner Good Samaritan.
Mr. Waggoner stated that he has made multiple visits to the site and accompanied an FDA inspector to Rx Formulations.
Mr. Waggoner stated that the Board Members have a copy of various visits and at the last Board Meeting the Board asked him to conduct a follow- up inspection. Mr. Waggoner stated that the
Board has received copies of that inspection.
Mr. Baker stated that he would like to clarify several points. Mr. Baker stated that the FDA referred to good manufacturing practices which are not the same as compounding regulations.
Mr. Baker stated that the products were not patient specific because they were being made for
hospital use. Mr. Baker stated that Mr. Albright made the medications for stat orders due to
shortages. Mr. Baker stated that the products Mr. Albright made were not commercially available at the time due to shortages. Mr. Albright would only compound commercially available products if they were not available.
Mr. Baker stated that Mr. Albright that did not solicit Banner’s business. Mr. Baker stated that Mr. Albright was going to discontinue making any products for Banner in September because they were building their own pharmacy. Mr. Baker stated that Mr. Albright was contacted by Banner to continue compounding medications for them on a month to month basis because their
pharmacy was not ready.
Mr. Baker stated that Mr. Albright has canceled the contract and only compounds patient specific
medications. Mr. Baker stated that Mr. Albright does no batch compounding.
Dr. Foy asked Mr. Albright if he had any prior issues with the FDA. Mr. Albright stated that he did not have any previous issues with the FDA.
Dr. Musil asked Mr. Albright about USP 71 testing. Mr. Albright stated that if it is greater than 25 units then it must be tested.
Dr. Musil asked Mr. Albright if he prepared 40 units of 100 cc each how many are sent for testing. Mr. Albright replied 10% for testing.
Dr. Musil asked Mr. Albright why he only sent 5 mls for testing. Mr. Albright stated that the technician sent 5 ml but they would normally send 10%.
Dr. Musil asked about the product testing. Mr. Albright stated that the product was identified as calcium gluconate.
Dr. Musil asked about the fine crystals that were present in the product. Mr. Albright stated that
the pharmacist saw crystals in the product. Mr. Albright stated that they reviewed their lot
and procedures. Mr. Albright stated that the product is temperature sensitive and it could have been handled incorrectly.
Dr. Musil asked Mr. Albright if he had documentation supporting a 30 day beyond use date.
Mr. Albright stated that his understanding is that the product could be used for 30 days.
Dr. Musil stated that the product is a high risk product and should have an expiration date of
3 days.
Dr. Musil asked about the environmental concerns that were found by the FDA and the Board.
Mr. Albright stated that he has purchased a new autoclave.
Dr. Musil asked about the ceiling tiles if they met USP 797 and certification standards. Mr.
Albright stated that a technician had gauged the tiles with a mop. Mr. Albright stated that the ceiling tiles and the electrical outlet had been replaced.
Dr. Musil asked about bubble point testing that was noted by the Board Compliance Officer.
Mr. Albright stated that for filters up to 25mm no bubble point test is required. Mr. Albright stated that he uses a double filter.
Dr. Musil indicated that USP 797 requires bubble point testing. Mr. Albright stated that the products were sent for testing and there was no bacterial growth found in the product.
Dr. Musil discussed the practice of bringing trash can liners into the room with Mr. Albright.
Dr. Musil asked Mr. Albright if he quarantined the product when he made a batch. Mr. Albright replied yes. Dr. Musil told Mr. Albright that he needs to add the quarantine to his policies.
Dr. Musil asked Mr. Albright if he is monitoring the contaminants in his clean room.
Mr. Albright stated that he used a different method than the FDA to monitor the contaminants.
On motion by Dr. Musil and seconded by Ms. Rosas, the Board unanimously agreed to offer
Rx Formulations a consent agreement with the following terms:
1. 1 year suspension with the suspension stayed for 2 years
2. $3,000 fine
3. 2 inspections at the cost of the permit holder. After the second inspection
the permit holder must appear before the Board and discuss the findings.
If the pharmacy fails either inspection, they must appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
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The following individuals were present to discuss the complaint:
1. Troy Albright – Pharmacist – Respondent
2. Ken Baker – Legal Counsel for Mr. Albright
President Foy opened the discussion by asking Mr. Waggoner to give a brief overview of the complaint.
Mr. Waggoner stated that the Board Office received a call from Banner Good Samaritan Regional Medical Center on 11/27/2013 concerning the discovery of a contaminated vial of
Calcium Glucontate 10% injection. It was determined that the contaminated vials were made by Rx Formualtions.
Mr. Waggoner stated that he visited Banner Good Samaritan and Rx Formulations. Mr. Waggoner stated that he noticed the black particles in the vial at Banner Good Samaritan.
Mr. Waggoner stated that he has made multiple visits to the site and accompanied an FDA inspector to Rx Formulations.
Mr. Waggoner stated that the Board Members have a copy of various visits and at the last Board Meeting the Board asked him to conduct a follow- up inspection. Mr. Waggoner stated that the
Board has received copies of that inspection.
Mr. Baker stated that he would like to clarify several points. Mr. Baker stated that the FDA referred to good manufacturing practices which are not the same as compounding regulations.
Mr. Baker stated that the products were not patient specific because they were being made for
hospital use. Mr. Baker stated that Mr. Albright made the medications for stat orders due to
shortages. Mr. Baker stated that the products Mr. Albright made were not commercially available at the time due to shortages. Mr. Albright would only compound commercially available products if they were not available.
Mr. Baker stated that Mr. Albright that did not solicit Banner’s business. Mr. Baker stated that Mr. Albright was going to discontinue making any products for Banner in September because they were building their own pharmacy. Mr. Baker stated that Mr. Albright was contacted by Banner to continue compounding medications for them on a month to month basis because their
pharmacy was not ready.
Mr. Baker stated that Mr. Albright has canceled the contract and only compounds patient specific
medications. Mr. Baker stated that Mr. Albright does no batch compounding.
Dr. Foy asked Mr. Albright if he had any prior issues with the FDA. Mr. Albright stated that he did not have any previous issues with the FDA.
Dr. Musil asked Mr. Albright about USP 71 testing. Mr. Albright stated that if it is greater than 25 units then it must be tested.
Dr. Musil asked Mr. Albright if he prepared 40 units of 100 cc each how many are sent for testing. Mr. Albright replied 10% for testing.
Dr. Musil asked Mr. Albright why he only sent 5 mls for testing. Mr. Albright stated that the technician sent 5 ml but they would normally send 10%.
Dr. Musil asked about the product testing. Mr. Albright stated that the product was identified as calcium gluconate.
Dr. Musil asked about the fine crystals that were present in the product. Mr. Albright stated that
the pharmacist saw crystals in the product. Mr. Albright stated that they reviewed their lot
and procedures. Mr. Albright stated that the product is temperature sensitive and it could have been handled incorrectly.
Dr. Musil asked Mr. Albright if he had documentation supporting a 30 day beyond use date.
Mr. Albright stated that his understanding is that the product could be used for 30 days.
Dr. Musil stated that the product is a high risk product and should have an expiration date of
3 days.
Dr. Musil asked about the environmental concerns that were found by the FDA and the Board.
Mr. Albright stated that he has purchased a new autoclave.
Dr. Musil asked about the ceiling tiles if they met USP 797 and certification standards. Mr.
Albright stated that a technician had gauged the tiles with a mop. Mr. Albright stated that the ceiling tiles and the electrical outlet had been replaced.
Dr. Musil asked about bubble point testing that was noted by the Board Compliance Officer.
Mr. Albright stated that for filters up to 25mm no bubble point test is required. Mr. Albright stated that he uses a double filter.
Dr. Musil indicated that USP 797 requires bubble point testing. Mr. Albright stated that the products were sent for testing and there was no bacterial growth found in the product.
Dr. Musil discussed the practice of bringing trash can liners into the room with Mr. Albright.
Dr. Musil asked Mr. Albright if he quarantined the product when he made a batch. Mr. Albright replied yes. Dr. Musil told Mr. Albright that he needs to add the quarantine to his policies.
Dr. Musil asked Mr. Albright if he is monitoring the contaminants in his clean room.
Mr. Albright stated that he used a different method than the FDA to monitor the contaminants.
On motion by Dr. Musil and seconded by Ms. Rosas, the Board unanimously agreed to offer
Rx Formulations a consent agreement with the following terms:
1. 1 year suspension with the suspension stayed for 2 years
2. $3,000 fine
3. 2 inspections at the cost of the permit holder. After the second inspection
the permit holder must appear before the Board and discuss the findings.
If the pharmacy fails either inspection, they must appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
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